Welcome!

News Feed Item

TiGenix: Positive Interim Safety Results of Phase IIa Rheumatoid Arthritis Study With Allogeneic Adult Stem Cells "Cx611"

LEUVEN, BELGIUM and MADRID, SPAIN -- (Marketwire) -- 12/19/12 -- TiGenix (EURONEXT BRUSSELS: TIG), the European leader in cell therapy, announced today positive interim safety results of its Phase IIa study of Cx611 in rheumatoid arthritis (RA). Cx611 is an intravenously injected suspension of expanded allogeneic adult stem cells derived from human adipose (fat) tissue. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders.

The interim results cover the first three months of the Phase IIa's six-month follow-up, and the data are still blinded. The primary endpoint of this study is safety, and the data collected so far support the good safety profile of all three doses of Cx611. Only two patients (4%) have suffered serious adverse events and only in one case (2%) it led to discontinuation of the treatment. All other side effects were mild and transient.

"We are delighted to report that the safety profile of Cx611 appears to be excellent," said Eduardo Bravo, CEO of TiGenix. "We have recruited patients who have failed at least two biologicals. If, in addition to this promising safety data, we can demonstrate a first indication of efficacy in this difficult to treat patient population, we will have a strong rationale to move forward with this product. We are looking forward to reporting the final results of the study at the end of April 2013."

About TiGenix

TiGenix NV (EURONEXT BRUSSELS: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.

Forward-looking information
This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

For more information:
Eduardo Bravo
Chief Executive Officer
[email protected]

Claudia D'Augusta
Chief Financial Officer
[email protected]

Hans Herklots
[email protected]
+32 16 39 60 97

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Cloud-based NCLC (No-code/low code) application builder platforms empower everyone in the organization to quickly build applications and executable processes that broaden access, deepen collaboration, and enhance transparency for all team members. Line of business owners (LOBO) and operations managers know best their part of the business and their processes. IT departments are beginning to leverage NCLC platforms to empower and enable LOBOs to lead the innovation, transform the organization, an...
As enterprises around the world struggle with their digital transformation efforts, many are finding that innovative digital teams are moving much faster than their hidebound IT organizations. Rather than struggling to convince traditional IT to get with the digital program, executives are taking advice from IT research firm Gartner, and encouraging existing IT to continue in their desultory ways. However, many CIOs are realizing the dangers of following Gartner’s advice. The central challenge ...
Unless you don’t use the internet, don’t live in California, or haven’t been paying attention to the recent news… you should be aware that self-driving cars are on their way to becoming a reality. I have seen them – they are real. If you believe in the future reality of self-driving cars, then continue reading on. If you don’t believe in the future possibilities, then I am not sure what to do to convince you other than discuss the very real changes that will roll out with the consumer producti...
Cloud Object Storage is effectively infinitely scalable and boasts the lowest total costs. But cloud SLAs and T&Cs are traditionally optimized for huge customers like Netflix, so applications demanding better confidentiality or higher availability typically can’t reap the benefits of public cloud storage. In his session at 18th Cloud Expo, Don Martin, CTO of Security First Corp, will provide an overview of innovative technologies available today – secret sharing and information dispersal algori...
There is an ever-growing explosion of new devices that are connected to the Internet using “cloud” solutions. This rapid growth is creating a massive new demand for efficient access to data. And it’s not just about connecting to that data anymore. This new demand is bringing new issues and challenges and it is important for companies to scale for the coming growth. And with that scaling comes the need for greater security, gathering and data analysis, storage, connectivity and, of course, the...
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vice president of product management, IoT solutions at GlobalSign, will teach IoT developers how t...
The pace of innovation, vendor lock-in, production sustainability, cost-effectiveness, and managing risk… In his session at 18th Cloud Expo, Dan Choquette, Founder of RackN, will discuss how CIOs are challenged finding the balance of finding the right tools, technology and operational model that serves the business the best. He will discuss how clouds, open source software and infrastructure solutions have benefits but also drawbacks and how workload and operational portability between vendors...
When it comes to IoT in the enterprise, namely the commercial building and hospitality markets, a benefit not getting the attention it deserves is energy efficiency, and IoT's direct impact on a cleaner, greener environment when installed in smart buildings. Until now clean technology was offered piecemeal and led with point solutions that require significant systems integration to orchestrate and deploy. There didn't exist a 'top down' approach that can manage and monitor the way a Smart Buildi...
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
Digital payments using wearable devices such as smart watches, fitness trackers, and payment wristbands are an increasing area of focus for industry participants, and consumer acceptance from early trials and deployments has encouraged some of the biggest names in technology and banking to continue their push to drive growth in this nascent market. Wearable payment systems may utilize near field communication (NFC), radio frequency identification (RFID), or quick response (QR) codes and barcodes...